Philips Recalls Vereos PET/CT Systems Due to Cover Misalignment
Philips Medical Systems is recalling 70 Vereos PET/CT systems because misaligned covers may create gaps or protrude into the imaging bore.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical defect (misaligned covers) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 70 units of the Vereos PET/CT, Model No. 882446. These systems are used for Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) imaging to detect and diagnose various diseases.
The recall is due to a defect where the front and rear covers may be misaligned. This misalignment can result in gaps between the cover parts or cause the cover to protrude into the bore diameter of the machine.
The affected units were distributed worldwide, including in the United States and various foreign countries. Specific serial numbers for the 70 affected units are listed in the official recall documentation. Users should contact Philips Medical Systems for instructions on how to address this issue.
The recalled product
- Product
- Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 70
Distribution
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